Name: Predicase
Price: 199 USD

K-number	K170993
Device name	QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
Applicant	Inova Diagnostics, Inc.
Product code	NXO
Device class	Class II
Decision date	Dec 22, 2017
Decision	Substantially Equivalent
Regulation	866.5180

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Source

View the full FDA submission: accessdata.fda.gov

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QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer

Everything you need for a 510(k) submission. Nothing you don't.